Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500364
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
Knotless Implants as An Alternative for Capsular Closure in Primary Hip Arthroscopy A Prospective Multi-Center Study
Sponsor:
American Hip Institute
Organization:
American Hip Institute
Study Overview
Official Title:
Knotless Implants as An Alternative for Capsular Closure in Primary Hip Arthroscopy A Prospective Multi-Center Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to see if the Arthrex LoopLocTM device is better for capsular closure during hip arthroscopy than other treatments available
The hip capsule is the tissue that surrounds your hip joint It stabilizes and supports your hip joint During hip arthroscopy this tissue must be cut through in order to perform the hip arthroscopy Once the hip arthroscopy is completed the surgeon might repair the capsule Current ways of repairing the capsule include knotted suture that might irritate structures around the hip leading to the possible formation of scar tissue and pain The Arthrex LoopLocTM device is knotless and may lower the presence of irritation and scar tissue around the hip after surgery and might lead to better outcomes
Therefore researchers will compare patients who had the LoopLocTM device used to close their hip capsule during surgery to those who did not have the device used to see if there is a difference in their outcomes following surgery
The hip capsule is the tissue that surrounds your hip joint It stabilizes and supports your hip joint During hip arthroscopy this tissue must be cut through in order to perform the hip arthroscopy Once the hip arthroscopy is completed the surgeon might repair the capsule Current ways of repairing the capsule include knotted suture that might irritate structures around the hip leading to the possible formation of scar tissue and pain The Arthrex LoopLocTM device is knotless and may lower the presence of irritation and scar tissue around the hip after surgery and might lead to better outcomes
Therefore researchers will compare patients who had the LoopLocTM device used to close their hip capsule during surgery to those who did not have the device used to see if there is a difference in their outcomes following surgery
Detailed Description:
The purpose of the study is to perform a prospective multi-center study evaluating the feasibility of a knotless capsular closure device in patients undergoing primary hip arthroscopy
All patients that meet study inclusion and exclusion criteria will then be informed about the study and given the IRB-approved consent form All patients will learn about the study during a clinic visit and will have the opportunity to review the consent form and ask questions All questions and concerns about study participation and the consent form will be addressed by staff and staff will ensure patient understanding of the consent form The study participant will then sign and date the consent form as well as the research staff obtaining consent Consent can be withdrawn at any time the participant chooses either verbally or in writing
Patients will be indicated by their physician for a capsular closuring using the LoopLocTM device These patients will follow up for two years with their providers and researchers who will collect their patient-reported and clinical outcomes Data from this study will be analyzed to determine if the LoopLocTM device for capsular closure has better outcomes than the alternative treatments available
All patients that meet study inclusion and exclusion criteria will then be informed about the study and given the IRB-approved consent form All patients will learn about the study during a clinic visit and will have the opportunity to review the consent form and ask questions All questions and concerns about study participation and the consent form will be addressed by staff and staff will ensure patient understanding of the consent form The study participant will then sign and date the consent form as well as the research staff obtaining consent Consent can be withdrawn at any time the participant chooses either verbally or in writing
Patients will be indicated by their physician for a capsular closuring using the LoopLocTM device These patients will follow up for two years with their providers and researchers who will collect their patient-reported and clinical outcomes Data from this study will be analyzed to determine if the LoopLocTM device for capsular closure has better outcomes than the alternative treatments available
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None